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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05 Jan - 19 Jan 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Remarks:
The Department of Health of the Government of the United Kingdom, UK
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Sprague-Dawley CD (Crl : CD® BR)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Ltd, Margate, Kent, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 211 – 225 g (males) and 208 – 232 g (females)
- Housing: animals were housed individually during the 24-h exposure and in groups of five of the same sex, for the remainder of the study, in polypropylene cages furnished with woodflakes.
- Diet: Rat and Mouse SQC Expanded Diet No. 1 (Special Diets Services Limited, Witham, Essex, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Example: 18-21
- Humidity (%): 47-67
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

OTHER
- On one occasion the temperature was below the limit specified in the protocol (19 °C). This deviation was considered not to affect the purpose or integrity of the study.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flanks were clipped
- % coverage: 10%
- Type of wrap if used: The test substance was held in contact with the skin with surgical gauze and semi-occluded with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed with cotton wool moistened with distilled water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):2.06 mL/kg bw
- Concentration (if solution): 100%
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed 30 min, 1, 2 and 4 h after dosing and subsequently daily for 14 days and individual body weights were determined prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
No effect on body weight was noted (see Table 1).
Gross pathology:
Necropsy revealed no substance-related findings.
Other findings:
Dermal reactions:
No signs of skin irritation were noted during the study period in any animal.

Any other information on results incl. tables

Table 1. Individual body weights and weekly body weight changes.

Dose level mg/kg bw

Animal number and sex

Bodyweight (g) at Day

Body weight gain (g)

during week

0

7

14

1

2

2000

1-0 Male

225

267

319

42

52

1-1 Male

215

259

307

44

48

1-2 Male

217

255

291

38

36

1-3 Male

211

253

300

42

47

1-4 Male

221

248

286

27

38

1-0 Female

208

219

226

11

7

1-1 Female

210

210

231

0

21

1-2 Female

232

246

257

14

11

1-3 Female

208

210

217

2

7

1-4 Female

213

216

220

3

4

 

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.